[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542871":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Jia Shen Tablet，4 tablets，take orally，2 times a day",[13],"Drug: Jia Shen Tablet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Jia Shen Tablet","Jia Shen Tablets contain 4 tablets (0.47 g per tablet), take orally, 2 times a day for 12 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rui Liu","CONTACT","022-86343626","liurui2@tasly.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.17667,39.14222,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":20,"phoneExt":20,"email":20},"Yuhong Huang",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100542871","phase-1-pharmacokinetic-and-pharmacodynamic-of-jia-shen-tablets-in-chronic-heart-failure-100542871",false,"NCT06348498","Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure","A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure","Inclusion Criteria:\n\n* Age 18-75 years, either sex;\n* Meet the diagnostic criteria for CHD and CHF;\n* Meet the TCM differentiation criteria of yang deficiency and blood stasis in CHF;\n* LVEF \\\u003C 40% (Modified Simpson's Method);\n* Class II to IⅢ for NYHA functional classification;\n* Receive Steady dose of standard medication for CHF for at least 2 weeks;\n* Understand the research requirements and are willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute heart failure or acute exacerbation of chronic heart failure;\n* HF caused by other heart diseases, such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g., hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis;\n* Patients with acute coronary syndrome within 30 days before receiving the trial drug，and the following situation within 6 months before receiving the trial drug，such as acute myocardial infarction，revascularization (e.g., PCI, CABG) or left ventricular reconstruction surgery, pacemaker implantation for cardiac resynchronization, and undergoing cardiothoracic surgery;\n* Expect to receive an implantable device (e.g. ICD, CRT), or revascularization (e.g. PCI, CABG), or other cardiovascular surgery during the trial period;\n* Severe arrhythmias \\[e.g., ventricular tachycardia, second degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) greater than 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome\\];\n* Combined with serious diseases of other systems, such as liver, kidney, hematopoietic system and other serious primary diseases, tumors, mental diseases, etc;\n* The presence of uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg), or the presence of hypotension (systolic blood pressure \\\u003C 80 mmHg and\u002For diastolic blood pressure \\\u003C 50 mmHg);\n* ALT or AST more than 3 times the upper limit of normal, and\u002For estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m2;\n* Glycosylated hemoglobin (HbA1c) ≥9.0%, or fasting blood glucose ≥13.9 mmol\u002FL;\n* Anemia (Hb \\\u003C 110 g\u002FL for women, Hb \\\u003C 120 g\u002FL for men);\n* Blood potassium is above the upper limit of normal;\n* Patients who tested positive for five hepatitis B tests (except surface antibodies) or hepatitis C, or anti-TP or HIV antibodies;\n* Patients with a history of drug abuse who test positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, THC, cocaine);\n* Women who are pregnant or nursing, or have a need to have children within 3 months after the last dose of the trial;\n* Participating in other studies and taking investigational drugs from other studies within 3 months prior to screening;\n* Allergic to Jiashen tablets or their ingredients;\n* Other situations judged by the researchers to be inappropriate for this study.","ALL","18 Years","75 Years",{"count":57,"type":58},18,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.",[64],"Heart Failure","2024-06-26",{"date":67,"type":68},"2024-06-28","ACTUAL",{"date":70,"type":68},"2024-04-09",{"date":72,"type":58},"2026-06-30",{"name":5,"class":6},1]